Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 263-196-9 | CAS number: 61791-64-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Diethanolamides as Used in Cosmetics; Amended Final Safety Assessment
- Author:
- Cosmetic Ingredient Safety Review (CIR) panel
- Year:
- 2 011
- Bibliographic source:
- 1101 17th Street, NW, Suite 412, Washington DC 20036-4702, United States of America
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- date of study not specified
Test material
- Reference substance name:
- Amides, coco, N,N-bis(hydroxyethyl)
- EC Number:
- 271-657-0
- EC Name:
- Amides, coco, N,N-bis(hydroxyethyl)
- Cas Number:
- 68603-42-9
- Molecular formula:
- C16H33NO
- IUPAC Name:
- N,N-Bis(2-hydroxyethyl)dodecanamide
Constituent 1
Results and discussion
Effect levels
- Remarks on result:
- other: Systemic effects attributable to the irritant nature of the test material were reported in two out of three available studies involving dermal application at doses up to 800 mg/kg bw/day.
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Systemic effects attributable to the irritant nature of the test material were reported in two out of three available studies involving dermal application at doses up to 800 mg/kg bw/day.
- Executive summary:
Study 1
A shaving cream containing 1.92% cocamide DEA was applied to the intact or abraded skin on the back of 8 New Zealand White (NZW) rabbits. Applications of 500 mg/kg of the test product were made 5x/wk for 4 wks. Dermal irritation was observed at both intact and abraded application sites. No systemic effects attributed to dosing were observed.
Study 2
The repeated-dose dermal toxicity of cocamide DEA (containing 18.2% free diethanolamine by wt) was evaluated using mice. Groups of 10 male and 10 female B6C3F1 mice were dosed with 50, 100, 200, 400, or 800 mg/kg bw cocamide DEA in ethanol (20-320 mg/mL), for 5 exposures/wk, for 14 wks. Vehicle only was applied to the negative control group. All animals survived until study termination. Dermal irritation was observed at the application sites of males and females of the 800 mg/kg dose group. Epidermal and sebaceous gland hyperplasia, parakeratosis, chronic active inflammation, and ulceration were observed; severity generally increased with increased dose. Final mean body weights and mean body weight gains were similar for test and control animals. The absolute liver and kidney weights and relative liver and kidney weights to body weights of males and females of the 800 mg/kg group, relative liver weights to body weights of females of the 400 mg/kg group, and absolute lung weights and relative lung weights to body weights of females of the 800 mg/kg group were significantly greater than for those of the controls. The epididymal spermatozoal concentration was significantly greater in males of the 800 mg/kg dose group.
Study 3
Groups of 20 male and 20 female F344/N rats were dosed dermally with 25, 50, 100, 200, or 400 mg/kg/bw cocamide DEA in ethanol (30-485 mg/ml), 5 exposures/wk, for 14 weeks; 10 rats per group were used for clinical chemistry and hematology evaluation. Vehicle only was applied to the negative control group. All animals survived until study termination. Dermal irritation was observed at the application sites of 2 males and one female of the 100 mg/kg group and in nearly all males and females of the 200 and 400 mg/kg dose groups. Lesions included epidermal and sebaceous gland hyperplasia, parakeratosis, chronic active inflammation, and ulceration; incidence and severity generally increased with increasing dose. Final mean body weights and mean body weight gains of males and females of the 200 and 400 mg groups were significantly less than those of the controls. Kidney weights of females of the 50 mg/kg group were significantly greater than those of the controls. Decreases in epididymal weights in 200 and 400 mg/kg males were attributed to decreased body weights. Changes in some hematology and clinical chemistry parameters were noted and the researchers stated there was an indication of altered lipid metabolism, as evidenced by decreased cholesterol and triglyceride concentrations. The incidences of renal tubule regeneration were greater in females of the 100 dose group, and the incidences and severities were greater in females of the 200 and 400 mg/kg dose groups, as compared to controls.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.